Describes standards, identifies the national standards, accreditation bodies, and lists the national testing organization(s) and conformity assessment bodies.
Products tested and certified in the United States to U.S. regulations and standards are likely to have to be retested and re-certified to EU requirements. This is a result of the EU’s different approach to the protection of the health and safety of consumers and the environment. Where products are not regulated by specific EU technical legislation, they are always subject to the EU’s General Product Safety Directive as well as to possible additional national requirements.
European Union legislation and standards created under the New Approach are harmonized across the Member States and European Economic Area countries to allow for the free flow of goods. An example of the New Approach is the CE marking.
The concept of the New Approach legislation is slowly disappearing as the New Legislative Framework (NLF), which entered into force in January 2010, was put in place to serve as a blueprint for existing and future CE marking legislation. Existing legislation has been reviewed to bring them in line with the NLF concepts, which means that, as of 2016, new requirements are being addressed and new reference numbers are to be used on declarations of conformity.
While harmonization of EU legislation can facilitate access to the EU Single Market, manufacturers should be aware that regulations (mandatory) and technical standards (voluntary) might also function as barriers to trade if U.S. standards are different from those of the European Union.
For agricultural standards, the establishment of harmonized EU rules and standards in the food sector has been ongoing for several decades. In January 2002, the EU publicized a general food law establishing a few general principles of EU food law. This Regulation introduced mandatory traceability throughout the feed and food chain as of Jan 1, 2005. For specific information on agricultural standards, please refer to the Foreign Agricultural Service’s website (https://www.usda-eu.org/)
There are also export guides to import regulations and standards available on the Foreign Agricultural Service’s website: FAIRS Export Certificate Report (https://www.usda-eu.org/trade-with-the-eu/eu-import-rules/certification/fairs-export-certificate-report/)
EU standards setting is a process based on consensus initiated by industry or mandated by the European Commission and carried out by independent standards bodies, acting at the national, European or international level. There is strong encouragement for non-governmental organizations, such as environmental and consumer groups, to actively participate in European standardization.
Many standards in the EU are adopted from international standards bodies such as the International Standards Organization (ISO). The drafting of specific EU standards is handled by three European standards organizations:
- CEN, European Committee for Standardization (https://www.cencenelec.eu/)
- CENELEC, European Committee for Electrotechnical Standardization (https://www.cencenelec.eu/)
- ETSI, European Telecommunications Standards Institute (https://www.etsi.org/
Standards are created or modified by experts in technical committees or working groups. The members of CEN and CENELEC are the national standards bodies of the Member States, which have “mirror committees” that monitor and delegate experts to participate in ongoing European standardization. CEN and CENELEC standards are sold by the individual Member States standards bodies. ETSI is different in that it allows direct participation in its technical committees from non-EU companies that have interests in Europe and provides some of its individual standards at no charge on its website. In addition to the three standards developing organizations, the European Commission plays an important role in standardization through its funding of the participation in the standardization process of small- and medium-sized companies and non-governmental organizations, such as environmental, labor and consumer groups. The Commission also provides money to the European standards bodies when it mandates development for harmonized standards that will be linked to EU legislation Mandates
– or requests (the Commission requests CEN/CENELEC or ESTI to develop standards) for standards.
Given the EU’s vigorous promotion of its regulatory and standards system, as well as its generous funding for its development, the EU’s regulatory and standards system has a wide reach. The EU’s regulatory and standards system extends well beyond the EU’s political borders to include affiliate members (countries which are hopeful of becoming full members in the future) such as the Western Balkan countries among others. Another category, called “companion standardization body” includes the standards organization of Morocco, Israel, Kazakhstan and Australia, among others which are not likely to become a CEN member or affiliate for political and geographical reasons.
To view what CEN and CENELEC are planning for future standardization, it is best to visit their websites. Other than their respective annual work plans, CEN’s “what we do” page provides an overview of standards activities by subject. Both CEN and CENELEC offer the possibility to search their respective database. ETSI’s (https://portal.etsi.org/home.aspx) portal links to ongoing activities.
The European standardization system and strategy was reviewed in 2011 and 2012. The new standards regulation 1025, adopted in November 2012, clarifies the relationship between regulations and standards and confirms the role of the three European standards bodies in developing future harmonized standards (EN). There is also an emphasis on referencing international standards where possible. For information, communication, and technology (ICT) products, the importance of interoperability standards has also been recognized. Through a relatively recent mechanism, a “Platform Committee”, reporting to the European Commission will decide which deliverables from fora and consortia might be acceptable for public procurement specifications. The European standards bodies have been encouraged to improve efficiency in terms of delivery and to look for ways to include more societal stakeholders in European standardization. The Joint Initiative on Standardization, launched in 2016, currently has a number of planned actions to improve European standardization. The joint initiative involves a large group of key stakeholders who are committed to deliver results by 2019.
NIST Notify U.S. Service
Member countries of the World Trade Organization (WTO) are required under the Agreement on Technical Barriers to Trade (TBT Agreement) to report to the WTO all proposed technical regulations that could affect trade with other Member countries. Notify U.S. is a free, web-based e-mail subscription service that offers an opportunity to review and comment on proposed foreign technical regulations that may affect your access to international markets. Register online at Internet URL: Standards Coordination Office USA WTO TBT Enquiry Point (https://tsapps.nist.gov/notifyus/data/index/index.cfm).
Testing, Inspection and Certification
Conformity Assessment is a mandatory step for the manufacturer in the process of complying with specific EU harmonized legislation. The purpose of conformity assessment is to ensure consistency of compliance during all stages, from design to production, and to facilitate acceptance of the final product. EU product legislation gives manufacturers some choice regarding conformity assessment, depending on the level of risk involved in the use of their product. These range from self-certification, type examination and production quality control system, to full quality assurance system. Conformity assessment bodies in individual Member States are listed in the New Approach Notification and Designated Organizations (NANDO) information system.
- NANDO: https://ec.europa.eu/growth/tools-databases/nando/
- French Accreditation Web Portal: https://www.cofrac.fr/
- French Standard Organization AFNOR Certification: https://www.afnor.org/
- Key Links to the French Standard Organization AFNOR Certification French label NF: https://marque-nf.com/.
To promote market acceptance of the final product, there are a number of voluntary conformity assessment programs. CEN’s certification system is known as the Keymark. Neither CENELEC nor ETSI offer conformity assessment services.
To sell products in the EU market of 28 Member States as well as in EFTA (Norway, Liechtenstein Iceland, Switzerland) and Turkey U.S. exporters are required to apply CE marking whenever their product is covered by specific product legislation. CE marking product legislation offers manufacturers several choices and requires decisions to determine which safety/health concerns need to be addressed, which conformity assessment module is best suited to the manufacturing process, and whether or not to use EU-wide harmonized standards. The CE marking process is very complex, and this section attempts to provide some background and clarification.
Products manufactured to standards adopted by CEN, CENELEC or ETSI, and referenced in the Official Journal as harmonized standards, are presumed to conform to the essential requirements of EU harmonized legislation. The manufacturer then applies the CE marking and issues a declaration of conformity. With these, the product will be allowed to circulate freely within the EU and EFTA. A manufacturer can choose not to use the harmonized EU standards, but then must demonstrate that the product meets the essential safety and performance requirements. Trade barriers occur when design, rather than performance, standards are developed by the relevant European standardization organization, and when U.S. companies do not have access to the standardization process through a European presence.
The CE marking addresses itself primarily to the national control authorities of the Member States, and its use simplifies the task of market surveillance of regulated products. As market surveillance was found lacking, the EU adopted the New Legislative Framework, which went into force in 2010. As mentioned before, this framework is like a blueprint for all CE marking legislation, harmonizing definitions, responsibilities, European accreditation and market surveillance.
The CE marking is not intended to include detailed technical information on the product, but there must be enough information to enable the inspector to trace the product back to the manufacturer or the local contact established in the EU. This detailed information should not appear next to the CE marking, but rather on the declaration of conformity (which the manufacturer or authorized agent must be able to provide at any time, together with the product’s technical file), or the documents accompanying the product.
Independent test and certification laboratories, known as notified bodies, have been officially accredited by competent national authorities to test and certify to EU requirements.
“European Accreditation - https://european-accreditation.org - is an organization representing nationally recognized accreditation bodies. Membership is open to nationally recognized accreditation bodies in countries in the European geographical area that can demonstrate that they operate an accreditation system compatible to appropriate EN and ISO/IEC standards.
Publication of technical regulations
Official Journal of the EU: https://eur-lex.europa.eu/oj/direct-access.html?locale=en
is the official publication of the European Union. It is published daily on the internet and consists of two series covering adopted legislation, as well as, case law, studies by committees. It also lists the standards reference numbers linked to legislation (Harmonized Standards: https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en)
National technical regulations are published on the Commission’s website: https://ec.europa.eu/growth/tools-databases/tris/en/ to allow other countries and interested parties to comment.
National Institute of Standards and Technology’s (NIST) Notify U.S. Service
Member countries of the World Trade Organization (WTO) are required under the Agreement on Technical Barriers to Trade (TBT Agreement) to report to the WTO all proposed technical regulations that could affect trade with other Member countries. The Notify U.S. Service is a free, web-based e-mail subscription service that offers an opportunity to review and comment on proposed foreign technical regulations that can affect your access to international markets. Register online at Internet URL: Notify U.S.
Contact Information E.U.:
U.S. Mission to the EU at https://useu.usmission.gov/
Jim Curtis, Standards Attaché
Tel: +32 2 811 42 44
Gordon Gillerman Standards Coordination Office
100 Bureau Dr.
Mail Stop 2100
Gaithersburg, Maryland 20899
Tel: (301) 975-4000
CEN- European Committee for Standardization
Avenue Marnix 17
B – 1000 Brussels, Belgium
CENELES- European Committee for Electrotechnical Standardization
Avenue Marnix 17
B – 1000 Brussels, Belgium
ETSI- European Telecommunications Standards Insitute
Route des Lucioles 650
F-06560 Valbonne France
SBS- Small Business Standards
4, Rue Jacques de Lalaing
ANEC- European Association for the Co-ordination of Consumer Representation in Standardization
Avenue de Tervuren 32, Box 27
B – 1040 Brussels, Belgium
ECOS- European Environmental Citizens Organization for Standardization
Rue d’Edimbourg 26
B – 1050 Brussels, Belgium
EOTA- European Organization for Technical Assessment
Avenue des Arts 40
B – 1040 Brussels, Belgium
- French Accreditation Web Portal: https://www.cofrac.fr/
- Cofrac/ Accreditation: https://www.cofrac.fr/quest-ce-que-laccreditation/
- Cofrac/ Accreditation/ Distinction: https://www.cofrac.fr/quest-ce-que-laccreditation/certification-et-accreditation-quelles-differences/
- French Standard Organization AFNOR Certification: https://www.afnor.org/en/get-certified/
- French National Testing Laboratories LNE: https://www.lne.fr/en
 An EN standard is a standard developed by CEN/CENELEC and ETSI at the request of the EC in order to meet the essential requirements or other provisions of relevant European Union harmonization legislation